By Stephen Young
By Stephen Young
By Stephen Young
By Jim Schutze
By Rachel Watts
By Lauren Drewes Daniels
He claims it was never his goal to build a more natural-looking breast. "That's a total misconception. I had been making perfectly natural breasts since 1979 [the year he entered private practice]."
When McGhan Medical Corp. approached him about designing a new implant in the early '90s, he had already been working with another implant manufacturer, researching whether implant rupture might be caused by folds and wrinkling in the implant's shell. After that manufacturer went out of business, he continued his work with McGhan. "Every bioengineer at an implant manufacturer told me that shell folding was one of the main reasons for shell failure," he says. "So how do you make the shell not fold? You put in more fill [either saline or silicone gel]." And the more you put in, the firmer it gets, the less chance the upper shell will fold or wrinkle when its fill decreases as the lower shell inevitably stretches and sags over time--or so surmised Tebbetts. With a fuller, firmer implant, there would be less chance of leaks, rupture and reoperation, all problems that the FDA had been concerned about.
He experimented with round saline-filled implants, he says, but the more they were filled "the more globular the breasts looked, like a softball." That's when he hit upon the idea of changing the shell's shape, "tapering the top of the shell so we could still put in enough [fill], but not have that excessive upper bulge," he says. "And that's how we did it." Tebbetts soft-pedals the aesthetics of his implant design, instead choosing to tout its safety features. "It's not an issue of the most natural breast. It's the most natural breast in conjunction with minimal shell folding."
McGhan, however, didn't see it the same way, at least not in its national ad campaign. When it brought the anatomic to market in the mid-'90s, it didn't promote the implant's longer shell life or wrinkle minimization to the readers of Glamour or Vogue. Instead, it introduced the Style 468 saline-filled implants as "Perfectly Natural...an anatomic design that reflects the shape of the natural breast." The manufacturer appeared to be playing off fears of women worried about buying a Baywatch boob, those that looked too round, high and obviously fake. "So, we designed our anatomical implant to be more like a woman's breast, "with a gentle slope and a more voluptuous, natural shape," one print advertisement claimed. Illustrations showing grapefruit vs. teardrop shapes accompanied the copy, which hailed the Style 468 as "revolutionary."
Women weren't the campaign's only targets. Plastic surgeons were invited to participate in McGhan's "Aesthetic Marketing Alliance" and become one of its "preferred surgeons." To attain this status, a doctor was obliged to pay an ongoing fee and implant "eight pair of Style 468" anatomicals. In exchange, the doctor would receive referrals and advertising support generated by McGhan's national ad campaign and Web site. In 1998, more than 1,000 physicians joined the Aesthetic Marketing Alliance, and the campaign generated more than 100,000 plastic surgeon inquiries by prospective patients. It was in every way a success, both for McGhan and Tebbetts, who acknowledges he had a "financial arrangement" with McGhan dating to 1993.
Many plastic surgeons had strong ethical reservations about the marketing alliance. "If it wasn't unethical, it was close to it," says veteran Dallas plastic surgeon Harlan Pollock, a regional spokesman for the ASPS. "Physicians must use their best medical judgment when advising a patient. A financial relationship with a manufacturer that requires you to use its implants might cloud that judgment." Doug Free, the general counsel for the California Society of Plastic Surgeons, expressed similar reservations. "Any form of consideration in exchange for patient referrals is unethical and illegal under California law." The ASPS voiced its own objections, and McGhan modified the program somewhat. But it ultimately died its own death, says one McGhan official, because it was too expensive for surgeons. And most preferred to use round implants, anyway, believing they did a comparable job at a lower price.
In May 2000, the FDA approved the safety of saline implants over the objections of women's advocacy groups that contended the agency reached the wrong result, failing to take fully into account their high complication rates. (More than 40 percent of patients receiving saline-filled implants had at least one complication within the first three years after surgery.) As part of the same approval process, the FDA prohibited implant manufacturers from marketing their shaped implants as "more anatomical," natural or having "better anatomical results."
"The burden of proof falls on the person who wants to make a positive statement that his product is better than another," explains Dr. Boyd Burkhardt, who served as a member of the FDA advisory panel that recommended the ban. "McGhan and Tebbetts had no proof. They couldn't pull it out of thin air."
The FDA had no objections, however, if manufacturers sought to promote their implants as "shaped" or "contoured." The labeling ban dealt another blow to the Style 468 anatomical, though it wouldn't be the last.
When Angie Jameson went to Dr. Tebbetts, she didn't know the difference between an anatomic implant and a round one. "I just didn't want my breasts entering the room before I did," she says. Tebbetts told her he had invented the anatomic, claimed it was state of the art. "He said when you stand up, it falls like a natural breast, " she recalls. "When you stand up with the round, it doesn't teardrop. It stays round."